Primary Care Management of Lower Urinary Tract Symptoms in Men (PriMUS)

Cardiff University

Status: Unknown

Conditions: Lower Urinary Tract Symptoms

Treatments: Diagnostic Test: Urodynamics

Study type: Interventional

Funder types: Other

Identifiers

NCT03520673

SPON 1553-16

10327305 (Registry Identifier)

Details and patient eligibility

About

The PriMUS Study aims to develop a clinical decision support tool to help GPs more accurately diagnose and manage LUTS in men. The study will recruit 880 men across three research hubs in Bristol, Newcastle and Wales. Men will all receive a series of simple index tests in primary care (following NICE Clinical Guidelines) and a urodynamics reference test. The study will then compare which combination of the simple index tests give the best prediction of the urodynamics result, which can then be incorporated into the clinical decision support tool.

Full description

Men are more likely to experience bothersome Lower Urinary Tract Symptoms (LUTS) as they get older. GPs follow standard processes to investigate signs of cancer, or more serious conditions but do not have access to tools to identify and manage more common symptoms of LUTS. This means men are likely to be referred to a urologist in secondary care, where they will receive advice or treatment that could have been given in primary care if GPs had more access to better diagnostic tools. The PriMUS Study will compare the results of the simple index tests, with the results of the urodynamic reference test, to identify which combination of simple index tests give the best prediction of the urodynamics diagnosis. The top performing simple index tests will be incorporated into the clinical decision support tool so that GPs can manage patients without needing invasive urodynamics. Follow up will be conducted 6 months post involvement; collating the treatment and management decisions made as a result of these procedures. The study will also consider and explore practicalities and acceptability of the urodynamic procedure and clinical decision support tool for both patients and clinical staff by conducting separate qualitative work.

Enrollment: 880 estimated patients

Sex: Male

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Men aged 16 years and over.

• Men who present to their GP with a complaint of one or more bothersome lower urinary tract symptoms (LUTS)#

• Men able and willing to give informed consent for participation in study

• Men able and willing to undergo all index tests and reference test, and complete study documentation.

  • This would include men on current treatment, but who are still symptomatic

Exclusion criteria

• Men with neurological disease or injury affecting lower urinary tract function

• Men with LUTS considered secondary to current or past invasive treatment or radiotherapy for pelvic disease

• Men with other contraindications to urodynamics e.g. Heart valve or joint replacement surgery within the last 3 months, immunocompromised/immunosuppressed.

• Men with indwelling urinary catheters or who carry out intermittent self-catheterisation

• Men whose initial assessment suggests that clinical findings are suggestive of possible:

  • prostate or bladder cancer*
  • recurrent or persistent symptomatic UTI**
  • retention e.g. palpable bladder after voiding'

• Men unable to consent in English or Welsh where a suitable translator is not available. This is a multi-centre study based in primary care, and we cannot guarantee translation facilities at all sites

  • According to standard NHS cancer pathways. If later deemed unlikely, then eligible for study participation.

    • If UTI successfully treated but LUTS remain, then eligible for study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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880 participants in 1 patient group

Development of Clinical Decision Support Tool

Other group

Description:

All men will receive the same series of simple index tests which will be compared with the results of the urodynamics reference test to identify which index tests give the best prediction of the urodynamic results. The data from the first cohort will develop the clinical decision support tool.

Treatment:

Diagnostic Test: Urodynamics